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Point of Care implementation of TB testing with ultra fast Local Heating PCR

The overall goal of this project is to bring the unique, ultra-fast Local Heating PCR technology and its current lab-proven prototype instruments from TRL 4 up to TRL 6 into clinical demonstration in tuberculosis centers in Italy,... ver más

30/11/2020

GNA

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

GNA BIOSOLUTIONS GMBH No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 8 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2020-11-30

NMBP-13-2017: Cross-cutting KETs for diagnostics...

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

8 Participantes

GNA

1.64M€ | Lider

Fraunhofer

484.85K€ | Participante

MULTID

325.00K€ | Participante

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Duración del proyecto: 36 meses Fecha Inicio: 2017-11-09
Fecha Fin: 2020-11-30

Líder del proyecto

GNA BIOSOLUTIONS GMBH No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 4M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto The overall goal of this project is to bring the unique, ultra-fast Local Heating PCR technology and its current lab-proven prototype instruments from TRL 4 up to TRL 6 into clinical demonstration in tuberculosis centers in Italy, Latvia, and Tanzania. This will imply a fully automated workflow on the instrument and all necessary reagents onboard of the integrated disposable cartridge, and a cloud based software for tracking epidemiological patterns. The application, ultra-fast point-of-care testing (POCT) for tuberculosis (TB) as well as emerging TB resistance markers, is an unmet healthcare need, not only in Europe, but globally. About one third of the human population is thought to carry the pathogen. One patient with active TB can typically infect 10-15 others. In the EU, the highest incidence rates are observed in Eastern Europe and the Baltic region. Furthermore, a very recent surge has been observed in some EU countries, e.g. in Germany, mainly due to higher mobility and migration. On top of this, multi-drug resistant (MDR) TB strains are becoming epidemic, causing exploding treatment costs. Active tuberculosis needs to be rapidly detected at hospitals, in- and out-patient clinics, specialized TB centers, jails, community centers, and shelter facilities. Such a test should be highly sensitive and capture all of the clinically relevant mutations that confer resistance in TB; if only one mutation escapes detection, the wrong treatment decision might be made, leaving the patient infected and capable of spreading resistant pathogens. Therefore, a panel of multiplexed markers will be adopted to LPCR in this project. It is ultimately the project’s ambition to develop a European-based contender in the emerging molecular POCT system space. The integrated TB/MDR TB LPCR system, a break-through-technology, aims specifically at impacting healthcare, TB knowledge and capacity building, and enabling future commercial success of the products.

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